Thank you for giving the National Pharmacy Association (NPA) the opportunity to comment on consultation ARM 44, the proposal to amend the legal classification of Galpharm Hayfever Eye drops containing sodium cromoglicate 2% from P to GSL.

Whilst the NPA from time to time has supported the reclassification of some medicinal products from P to GSL, when the supporting evidence shows that this would be beneficial, in this case we do not support the proposed change for a variety of reasons.

Safety

Despite the good safety record for the product in clinical use and through the pharmacy distribution model, we would strongly suggest that this safety record is maintained in part by the involvement of a healthcare professional, be that a general practitioner, an optometrist, or a pharmacist. This would change if it became available for general sale and would inevitably increase the risk of inappropriate use.

Whilst the proposed wording on the patient information leaflet includes restrictions to seek the advice of a pharmacist or doctor if there is no improvement over 2 days, it is, unfortunately, a fact that patients do not read all the information on a patient information leaflet and the NPA has concerns about patients misdiagnosing and mistreating conditions. This argument would also apply to the advice to seek professional help if the eye drops are required continuously for more than 14 days. Indeed recent research conducted by Tel Aviv University indicates that 50% of patients do not read the patient information leaflet for prescribed medicines1, we assert that this figure would be even lower for patients purchasing GSL products.

Other ocular conditions in which some symptoms may overlap include viral, bacteria, chlamydial conjunctivitis or even ophthalmic shingles and whilst a healthcare professional could routinely distinguish between these, it is highly unlikely that all lay patients would be able to do so accurately. If this type of misdiagnosis is coupled with the patient not reading the patient information leaflet and following the instructions to seek medical help, then the underlying conditions could remain untreated.

Accessibility

Whilst it is undeniable that access to sodium cromoglicate 2% eye drops would be increased by changing the classification, it is our opinion that access to pharmacy is readily available, with many pharmacies operating till late and with pharmacies increasingly present in supermarkets. A small restriction in accessibility is a small price to pay for the professional care provided by a pharmacy. Convenience must not be the only or predominant factor in the reclassification of medicinal products.

Furthermore we note that this application is driven by the commercial interests of Galpharm and is unsupported by either expert opinion or consumer organisations. There is no evidence to show that there is a desire for the consumer to have access to this medicinal product beyond the current existing avenues and it would be unwise to move from this situation unless a clear and demonstrable need or benefit exists.

Conclusion

Eyes are very important, and this is recognised by the common sense prevention of classification of medicinal eye ointments and eye drops as GSL products by the GSL order. We have seen no evidence in the proposal that convinces us that there is a consumer driven need for reclassification and also are highly sceptical that the safety record of the product itself can be extrapolated to cover possible misdiagnosis and the high possibility that patients will not read the patient information leaflets and seek professional advice when it is needed. The NPA therefore objects to the reclassification proposals.